Drug Use Investigation Of Champix (Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3,939
- 主要终点
- Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.
研究概览
简要总结
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
详细描述
All the patients whom an investigator prescribes the first Varenicline(Champix) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients need to be administered Varenicline(Champix) in order to be enrolled in the surveillance.
排除标准
- •Patients not administered Varenicline(Champix).
研究组 & 干预措施
Varenicline
Patients taking Varenicline.
干预措施: Varenicline (Drug)
结局指标
主要结局
Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.
时间窗: 24 weeks
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Age.
时间窗: 24 weeks
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.
时间窗: 24 weeks
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.
时间窗: 24 weeks
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.
时间窗: 24 weeks
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.
时间窗: 24 weeks
Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.
Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.
时间窗: 24 weeks
The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.
时间窗: 24 weeks
The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.
时间窗: 24 weeks
The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Number of Participants With Treatment Related Adverse Events.
时间窗: 24 weeks
Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
时间窗: 24 weeks
Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.
次要结局
- Number of Participants With Continuous Abstinence Situation by 52 Weeks.(52 weeks)